Safety, efficacy, and impact on gut microbial ecology of a Bifidobacterium longum subspecies infantis LMG11588 supplementation in healthy term infants: a randomized, double-blind, controlled trial in the Philippines
IntroductionBifidobacterium longum subspecies infantis (B. infantis) may play a key role in infant gut development. This trial evaluated safety, tolerability, and efficacy of B. infantis LMG11588 supplementation.MethodsThis randomized, placebo-controlled, double-blind study conducted in the Philippi...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2023-12-01
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| Series: | Frontiers in Nutrition |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fnut.2023.1319873/full |
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| author | Maria Rosario Z. Capeding Loudhie Cyd M. Phee Chang Ming Mario Noti Karine Vidal Gilles Le Carrou A. Frézal Janne Marie Moll Josef Korbinian Vogt Pernille Neve Myers Bjørn Henrik Nielsen Claire L. Boulangé Tinu Mary Samuel Bernard Berger Colin Ivano Cercamondi |
| author_facet | Maria Rosario Z. Capeding Loudhie Cyd M. Phee Chang Ming Mario Noti Karine Vidal Gilles Le Carrou A. Frézal Janne Marie Moll Josef Korbinian Vogt Pernille Neve Myers Bjørn Henrik Nielsen Claire L. Boulangé Tinu Mary Samuel Bernard Berger Colin Ivano Cercamondi |
| author_sort | Maria Rosario Z. Capeding |
| collection | DOAJ |
| description | IntroductionBifidobacterium longum subspecies infantis (B. infantis) may play a key role in infant gut development. This trial evaluated safety, tolerability, and efficacy of B. infantis LMG11588 supplementation.MethodsThis randomized, placebo-controlled, double-blind study conducted in the Philippines included healthy breastfed and/or formula-fed infants (14–21 days old) randomized for 8 weeks to a control group (CG; n = 77), or any of two B. infantis experimental groups (EGs): low (Lo-EG; 1*108 CFU/day; n = 75) or high dose (Hi-EG; 1.8*1010 CFU/day; n = 76). Primary endpoint was weight gain; secondary endpoints included stooling patterns, gastrointestinal symptoms, adverse events, fecal microbiome, biomarkers, pH, and organic acids.ResultsNon-inferiority in weight gain was demonstrated for Hi-EG and Lo-EG vs. CG. Overall, probiotic supplementation promoted mushy-soft stools, fewer regurgitation episodes, and increased fecal acetate production, which was more pronounced in the exclusively breastfed infants (EBF) and positively correlated with B. infantis abundance. In EBF, fecal pro-inflammatory cytokines (IL-1 beta, IL-8) were reduced. Strain-level metagenomic analysis allowed attributing the increased abundance of B. infantis in EGs versus CG, to LMG11588 probiotic colonization. Colonization by autochthonous B. infantis strains was similar between groups.DiscussionB. infantis LMG11588 supplementation was associated with normal infant growth, was safe and well-tolerated and promoted a Bifidobacterium-rich microbiota driven by B. infantis LMG11588 colonization without disturbing the natural dispersal of autochthonous B. infantis strains. In EBF, supplementation stimulated microbial metabolic activity and beneficially modulated enteric inflammation. |
| first_indexed | 2024-03-08T23:30:27Z |
| format | Article |
| id | doaj.art-1fbdfd23842e4deda7e8aeac7ba20389 |
| institution | Directory Open Access Journal |
| issn | 2296-861X |
| language | English |
| last_indexed | 2024-03-08T23:30:27Z |
| publishDate | 2023-12-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Nutrition |
| spelling | doaj.art-1fbdfd23842e4deda7e8aeac7ba203892023-12-14T13:59:41ZengFrontiers Media S.A.Frontiers in Nutrition2296-861X2023-12-011010.3389/fnut.2023.13198731319873Safety, efficacy, and impact on gut microbial ecology of a Bifidobacterium longum subspecies infantis LMG11588 supplementation in healthy term infants: a randomized, double-blind, controlled trial in the PhilippinesMaria Rosario Z. Capeding0Loudhie Cyd M. Phee1Chang Ming2Mario Noti3Karine Vidal4Gilles Le Carrou5A. Frézal6Janne Marie Moll7Josef Korbinian Vogt8Pernille Neve Myers9Bjørn Henrik Nielsen10Claire L. Boulangé11Tinu Mary Samuel12Bernard Berger13Colin Ivano Cercamondi14Asian Hospital and Medical Center, Muntinlupa City, PhilippinesAsian Hospital and Medical Center, Muntinlupa City, PhilippinesBiostatistics & Data, Nestlé Research, Lausanne, SwitzerlandNestlé Institute of Health Sciences, Nestlé Research, Société des Produits Nestlé S.A., Lausanne, SwitzerlandNestlé Institute of Health Sciences, Nestlé Research, Société des Produits Nestlé S.A., Lausanne, SwitzerlandNestlé Institute of Health Sciences, Nestlé Research, Société des Produits Nestlé S.A., Lausanne, SwitzerlandNestlé Institute of Health Sciences, Nestlé Research, Société des Produits Nestlé S.A., Lausanne, SwitzerlandClinical Microbiomics, Copenhagen, DenmarkClinical Microbiomics, Copenhagen, DenmarkClinical Microbiomics, Copenhagen, DenmarkClinical Microbiomics, Copenhagen, DenmarkNestlé Institute of Health Sciences, Nestlé Research, Société des Produits Nestlé S.A., Lausanne, SwitzerlandNestlé Product Technology Center – Nutrition, Société des Produits Nestlé S.A., Vevey, SwitzerlandNestlé Institute of Health Sciences, Nestlé Research, Société des Produits Nestlé S.A., Lausanne, SwitzerlandNestlé Product Technology Center – Nutrition, Société des Produits Nestlé S.A., Vevey, SwitzerlandIntroductionBifidobacterium longum subspecies infantis (B. infantis) may play a key role in infant gut development. This trial evaluated safety, tolerability, and efficacy of B. infantis LMG11588 supplementation.MethodsThis randomized, placebo-controlled, double-blind study conducted in the Philippines included healthy breastfed and/or formula-fed infants (14–21 days old) randomized for 8 weeks to a control group (CG; n = 77), or any of two B. infantis experimental groups (EGs): low (Lo-EG; 1*108 CFU/day; n = 75) or high dose (Hi-EG; 1.8*1010 CFU/day; n = 76). Primary endpoint was weight gain; secondary endpoints included stooling patterns, gastrointestinal symptoms, adverse events, fecal microbiome, biomarkers, pH, and organic acids.ResultsNon-inferiority in weight gain was demonstrated for Hi-EG and Lo-EG vs. CG. Overall, probiotic supplementation promoted mushy-soft stools, fewer regurgitation episodes, and increased fecal acetate production, which was more pronounced in the exclusively breastfed infants (EBF) and positively correlated with B. infantis abundance. In EBF, fecal pro-inflammatory cytokines (IL-1 beta, IL-8) were reduced. Strain-level metagenomic analysis allowed attributing the increased abundance of B. infantis in EGs versus CG, to LMG11588 probiotic colonization. Colonization by autochthonous B. infantis strains was similar between groups.DiscussionB. infantis LMG11588 supplementation was associated with normal infant growth, was safe and well-tolerated and promoted a Bifidobacterium-rich microbiota driven by B. infantis LMG11588 colonization without disturbing the natural dispersal of autochthonous B. infantis strains. In EBF, supplementation stimulated microbial metabolic activity and beneficially modulated enteric inflammation.https://www.frontiersin.org/articles/10.3389/fnut.2023.1319873/fullB. infantis LMG11588infant growthsafetyBifidobacterium-rich microbiotaautochthonous strains |
| spellingShingle | Maria Rosario Z. Capeding Loudhie Cyd M. Phee Chang Ming Mario Noti Karine Vidal Gilles Le Carrou A. Frézal Janne Marie Moll Josef Korbinian Vogt Pernille Neve Myers Bjørn Henrik Nielsen Claire L. Boulangé Tinu Mary Samuel Bernard Berger Colin Ivano Cercamondi Safety, efficacy, and impact on gut microbial ecology of a Bifidobacterium longum subspecies infantis LMG11588 supplementation in healthy term infants: a randomized, double-blind, controlled trial in the Philippines Frontiers in Nutrition B. infantis LMG11588 infant growth safety Bifidobacterium-rich microbiota autochthonous strains |
| title | Safety, efficacy, and impact on gut microbial ecology of a Bifidobacterium longum subspecies infantis LMG11588 supplementation in healthy term infants: a randomized, double-blind, controlled trial in the Philippines |
| title_full | Safety, efficacy, and impact on gut microbial ecology of a Bifidobacterium longum subspecies infantis LMG11588 supplementation in healthy term infants: a randomized, double-blind, controlled trial in the Philippines |
| title_fullStr | Safety, efficacy, and impact on gut microbial ecology of a Bifidobacterium longum subspecies infantis LMG11588 supplementation in healthy term infants: a randomized, double-blind, controlled trial in the Philippines |
| title_full_unstemmed | Safety, efficacy, and impact on gut microbial ecology of a Bifidobacterium longum subspecies infantis LMG11588 supplementation in healthy term infants: a randomized, double-blind, controlled trial in the Philippines |
| title_short | Safety, efficacy, and impact on gut microbial ecology of a Bifidobacterium longum subspecies infantis LMG11588 supplementation in healthy term infants: a randomized, double-blind, controlled trial in the Philippines |
| title_sort | safety efficacy and impact on gut microbial ecology of a bifidobacterium longum subspecies infantis lmg11588 supplementation in healthy term infants a randomized double blind controlled trial in the philippines |
| topic | B. infantis LMG11588 infant growth safety Bifidobacterium-rich microbiota autochthonous strains |
| url | https://www.frontiersin.org/articles/10.3389/fnut.2023.1319873/full |
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